Ann Marie Marciarille: Pharmacy Compounding, Safety, and Regulation

AMM:

Missouri State of Mind: Pharmacy Compounding - Everything Old is New Again: [T]hat funny feeling of deja vu all over again… watching… [the] meningitis outbreak…. In June of 2002, the unevenly regulated nature of pharmacy compounding was all over the press in northern California because of the death of George Stahl from bacterial meningitis traceable to to a cortisone shot using pharmacy-compounded medical supplies. Mass prescription drug manufacturing is heavily regulated by the Food and Drug Administration. Compounding pharmacies… are much more lightly regulated….

Compounding a prescription drug without a common preservative might be the only way to make that medication available to a patient allergic to the preservative, for example.

But there's also a reimbursement story here. FDA-approved drugs cost more. Regulation is not free. Compounding may be an attempt to circumvent expensive regulation. It certainly raises more questions when the compounding pharmacy is producing a significant volume of a lower priced drug to be sold to the health care providers of the standard patients. The conduit of the compounded medication is the health care provider paid a set fee for the medication and its administration -- someone seeking a higher profit margin by sourcing a product at a better non-regulated or lightly regulated price….

Just as pharmacist compounding is as old as the profession itself, our cyclical panic over this practice is a perennial. In particular, the FDA's Pharmacy Compounding Committee of the 1990's tried to promote a stautory ban on sterile products (like cortisone shots) that for safety reasons should be determined to be demonstrably difficult to compound safely…. [T]he statute failed at the Supreme Court on First Amendment grounds… Thompson v. Western States Medical Center…. Justice O'Connor may have had the truth of it precisely inverted. The truth is that larger scale compounding is quite lucrative, for compounding pharmacies and their health care provider purchasers alike.

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Ann Marie Marciarille: Pharmacy Compounding, Safety, and Regulation

AMM:

Missouri State of Mind: Pharmacy Compounding - Everything Old is New Again: [T]hat funny feeling of deja vu all over again… watching… [the] meningitis outbreak…. In June of 2002, the unevenly regulated nature of pharmacy compounding was all over the press in northern California because of the death of George Stahl from bacterial meningitis traceable to to a cortisone shot using pharmacy-compounded medical supplies. Mass prescription drug manufacturing is heavily regulated by the Food and Drug Administration. Compounding pharmacies… are much more lightly regulated….

Compounding a prescription drug without a common preservative might be the only way to make that medication available to a patient allergic to the preservative, for example.